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A Comparison of Infection Rates Between Two Surgical Sites

Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Corneal Toxicity; Ototoxicity; Surgical Site Infection

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Jerry Brewer, MD, Principal Investigator, Affiliation: Mayo Clinic

Summary

Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?

Clinical Details

Official title: A Comparative Assessment Between Two Surgical Sites of the Rate of Corneal Toxicity and Ototoxicity With the Use of Povidone-iodine Versus Chlorhexidine-alcohol for Facial Lesions Treated With Mohs Micrographic Surgery

Study design: Observational Model: Cohort, Time Perspective: Prospective

Detailed description: The intent of this proposed prospective observational cohort study is to determine if there is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the face has previously been associated with corneal toxicity and ototoxicity. This study will help to further define previously reported risks of corneal toxicity and ototoxicity associated with the use of a chlorhexidine solution on the face.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients undergoing an outpatient cutaneous surgical procedure on the face.

Exclusion Criteria:

- Those who do not consent to participation

- Those undergoing cutaneous surgery for a lesion on the eyelid margin

- Patients with a history of ongoing eye pain

- History of a pre-existing corneal ulcer within 12 months prior to surgery

- History of a perforated tympanic membrane

- Patients with an active infection at the surgical site at the time of surgery.

- If post-operative follow-up is not completed, the study subject will be excluded from

the analysis.

Locations and Contacts

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Jerry Brewer, MD, Email: brewer.jerry@mayo.edu
Additional Information

Starting date: January 2011
Last updated: May 24, 2012

Page last updated: February 07, 2013

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